RPE Capabilities in Practice.

Background

Postgraduate Certificate Research Practice Experience Module Capabilities in Practice

Postgraduate Diploma Research Practice Experience Module Capabilities in Practice

Further information

Background

Learners completing a Postgraduate Certificate, Postgraduate Diploma or Master’s degree aligned to the Clinician Researcher Credentials Framework will develop the skills needed to begin to contribute and eventually lead clinical research in everyday clinical settings.

Graduates of courses aligned with the Framework will ultimately be prepared to support and deliver vital projects to improve patient treatments and outcomes. Learners on the course will need to complete the Research Practice Experience (RPE) modules. These modules require learners to gain experiences to enable them to be entrusted to take responsibility for specific areas of clinical research delivery. These are detailed in the Capabilities in Practice (CiPs) which are included below.

To be a RPE supervisor, you will need to be able to find the learner various face to face or remote shadowing opportunities to develop these skills within your project and/or networks. Therefore please study the CiPs below to determine if this is possible before taking any further steps.

Postgraduate Certificate Research Practice Experience Module Capabilities in Practice

Graduate celebrating receiving their certificate

CiP1: To develop an in-depth understanding of the clinical research ecosystem

The importance, value, and diversity of clinical research in healthcare.
The importance and value of networked clinical research.
The culture and landscape of research.
How does clinical research work?
Who are the key personages in research (to include the roles and responsibilities of a sponsor, Chief, Principal and Sub- or Co- Investigator; Back up Physician; Blinded / Masked Physician or Assessor; the role of HRA / MHRA in approving studies, other regulatory agencies)?
Key teams who may be external to the core research team but are critical to the delivery of clinical research.
Research and Development departments (or their equivalent): how do they operate? How do they fit into the hospital structure?
Research Networks (e.g. CRNs, research networks of major charities, professional body research networks or equivalent research networks): what can the network support? How do you navigate the system to secure the support you need?
Public and patient engagement and involvement (PPIE) in research – how this influences the design and conduct of studies and prioritises research questions that need to be answered.
Study feasibility.

CiP2: To manage the steps involved in data collection within a networked clinical research study*

Checking it is appropriate for you to contribute to clinical research study.
Site initiation and selection.
Recruitment strategy.
Sampling (people, activities, records, time periods, etc) for this networked clinical research study.
Screening participants for studies.
Recruiting participants.
Informed consent process, including receiving consent in studies that include participants that lack capacity and managing consent for online studies.
Taking patients through pathways.
Taking participants through the various study milestones.
Trial Treatments, where applicable (to include preventative treatments, surgery, radiotherapy, and other interventions).
Recording data and checking for accuracy.
Research Specific Audits and monitoring.
Safety reporting (initial and follow up).
Closing a study, and the Principal Investigator’s role within that part of the process.

*Learners are unlikely to complete all tasks in CiP2; their ability to complete specific tasks will be context and study dependent. What matters is that the supervisor can confidently entrust the learner to manage the steps involved in data collection within a networked clinical research study (under the supervision of a Principal Investigator).

Postgraduate Diploma Research Practice Experience Module Capabilities in Practice

CiP3: To identify and evaluate the key processes of research (including what steps must happen before a research study can begin)

Defining and refining the research question.
Designing a feasible study and using approaches aligned with answering the research question (including being able to evaluate the strengths and weaknesses of different approaches for different types of research question and contexts).
Costing a research study.
Contracts.
Methods of data collection (both quantitative and qualitative).
Data protection and GDPR considerations.
Research ethics and the broader concept of research integrity.
Obtaining peer review and all necessary permissions, at both the point of applying for funding and during the review process.
Regulation.
Securing funding.
Evaluating whether research processes have been managed satisfactorily (in order to decide whether to join a research study).

CiP4: To understand other stages within a networked clinical research study

Pooling data from multiple sites.
Interpreting the data.
Sharing the data.
Disseminating results to different audiences and keeping your participants linked in; this could include contributing to, for example, presentations and publications.
Planning for follow-up and subsequent studies.